Slide 1: Corporate presentation
August 7, 2023 nasdaq: axgn Corporate presentation
Slide 2: Safe harbor statement
2 This presentation contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations or predictions of future conditions, events, or results based on various assumptions and management's estimate
Slide 3: The Axogen platform for nerve repair
3 The Axogen platform for nerve repair revolutionizing the science of nerve repair® • Exclusively focused on peripheral nerve repair with a differentiated platform • 10+ years of demonstrated clinical outcome consistency • Over 200 peer-reviewed clinical publications • Over 75,000 Avance® Nerve Graf
Slide 4: The function of nerves
4 The function of nerves Nerves are like wires • Transfer signals across a network • If cut, data cannot be transferred • If crushed, short circuits and data corruption may occur The peripheral nervous system is a vast network from every organ to and from the brain • Sensory • Motor • Mixed Nerves c
Slide 5: A comprehensive platform for addressing nerve injuries
5 A comprehensive platform for addressing nerve injuries revolutionizing the science of nerve repair® CONFIDENTIAL TerminationProtectionConnection
Slide 6: Targeted nerve markets (U.S.)
Targeted nerve markets (U.S.) 6 Trauma $1.9B Breast $250M OMF $300M Carpal & Cubital Tunnel $270M U.S. potential procedural estimates >900,000** • Trauma: > 700,000 • Carpal Tunnel Revisions & Cubital Tunnel: 130,000 • Oral Maxillofacial (OMF): 56,000 • Breast Neurotization Procedures: 15,000 *$2.7B
Slide 7: Opportunities in nerve repair
7 P IL L A R 5 Opportunities in nerve repair P IL L A R 4 P IL L A R 3 Pain Iatrogenic injuries, post-traumatic, migraine, TKA and TKH pain, amputations, symptomatic neuromas, and nerve compressions Core business anchored in Trauma and Upper Extremity, and expanded to Breast, OMF and Pain. Further M
Slide 8: Two primary categories: scheduled and emergent
As we have introduced new applications, we now think about our business along two primary categories revolutionizing the science of nerve repair™ 8 Emergent Trauma Procedure Examples Transected Sensory nerves Transected Mixed/Motor nerves Non-transected nerve injury Scheduled Procedure Examples Brea
Slide 9: Scheduled procedures
Scheduled procedures involve a patient seeking relief of a condition caused by a nerve defect or surgical procedure revolutionizing the science of nerve repair™ 9 ▪ Patients seeking a scheduled procedure weeks or months in advance allows patients to advocate for solutions that may improve quality of
Slide 10: Emergent trauma cases
Emergent trauma cases generally result from injuries that initially present in an ER revolutionizing the science of nerve repair™ 10 ▪ Significant number of nerve injuries typically referred to and completed by a specialist either immediately or within a few days following the injury with limited po
Slide 11: Delivering strong revenue growth & gross margins
11 Delivering strong revenue growth & gross margins Revenue by Category 81.1% Gross Margin for the quarter ended June 30, 2023 U.S. $ in millions revolutionizing the science of nerve repair® $41.1 $60.4 $83.9 $106.7 $112.3 $127.4 $138.6 2016 2017 2018 2019 2020 2021 2022 Annual Revenue 22% CAGR $34.
Slide 12: Growth Drivers
Growth Drivers revolutionizing the science of nerve repair™ 12August 7, 2023 • Recent clinical data published within the past year will support increased adoption particularly with middle adopters – RECON – Meta Analysis of clinical outcomes and Medicare Economic Data – Premier Economic Data • New P
Slide 13: 2023 Annual Financial Guidance
2023 Annual Financial Guidance 13 • Full-year 2023 revenue is expected to be between $154 million and $159 million revolutionizing the science of nerve repair® • Gross margin will be reduced with the transition to the new processing facility in the third and fourth quarters • Expect full year gross
Slide 14: Axogen Processing Center (APC)
14 Axogen Processing Center (APC) • Completed construction and expect to start processing tissue in August 2023 • Supports BLA requirements for Avance Nerve Graft. • Provides 3x increase of current capacity; and allows expansion for future growth revolutionizing the science of nerve repair®
Slide 15: Product Portfolio
Product Portfolio revolutionizing the science of nerve repair™ 15August 7, 2023
Slide 16: Traditional transection repair options are suboptimal
Traditional TRANSECTION repair options are suboptimal 16 SUTURE Direct suture repair of no-gap injuries • Common repair method • May result in tension to the repair leading to ischemia • Concentrates sutures at the coaptation site AUTOGRAFT Traditional method despite several disadvantages • Secondar
Slide 17: Processed human nerve allograft for bridging nerve gaps
17 25 µm Processed human nerve allograft for bridging nerve gaps Clinically studied off-the-shelf alternative • A biologically active nerve therapy with more than ten years of comprehensive clinical evidence • 82-84% meaningful recovery in sensory, mixed and motor nerve gaps in multi-center study22
Slide 18: Traditional compression repair options are suboptimal
Traditional COMPRESSION repair options are suboptimal 18 VEIN WRAPPING Autologous vein • Barrier to attachment to surrounding tissue • Requires extra time and skill to perform spiral wrapping technique • Second surgery site HYPOTHENAR FAT PAD Autologous vascularized flap • Barrier to attachment to s
Slide 19: Axogen solution for compression repair
19 Axogen solution for COMPRESSION repair Minimally processed porcine extracellular matrix for wrapping and protecting injured peripheral nerve Protects repair site from surrounding tissue • Processing results in an implant that works with the body’s natural healing process33 • Minimizes soft tissue
Slide 20: Axoguard HA+ Nerve Protector
Axoguard HA+ Nerve Protector™ designed for short and long-term protection Lubrication layer: ▪ Protects nerve in the early critical phase of healing ▪ Enhance nerve gliding for nerve protection applications where nerve mobility is critical and aids in minimizing soft tissue attachments ECM Base Memb
Slide 21: Traditional stump neuroma options are suboptimal
Traditional STUMP NEUROMA options are suboptimal 21 TRACTION NEURECTOMY Nerve placed in traction and cut to allow for retraction • Simply resecting the nerve results in subsequent neuroma formation and risk of secondary surgery • Causes traction injury • High risk of recurrence 36 BURYING IN MUSCLE/
Slide 22: Axogen solution for stump neuroma
22 Axogen solution for STUMP NEUROMA Proprietary small intestine submucosa (SIS) matrix designed to separate the nerve end from the surrounding environment to protect it from mechanical stimulation and reduce painful neuroma formation. Protects and isolates • Reduces the development of symptomatic o
Slide 23: Avance Patents and Regulatory Landscape
23 Avance Patents and Regulatory Landscape Avance nerve graft is processed and distributed in accordance with US FDA requirements for Human Cellular and Tissue-based Products (HCT/P) Issued U.S. Patents (additional patents pending) Axogen has Enforcement Discretion from FDA allowing continued sales
Slide 24: Market development strategy
24 Market development strategy B u il d M a rk e t A w a re n e s s G ro w B o d y o f C li n ic a l E v id e n c e E x e c u te S a le s P la n E x p a n d P ro d u c t P ip e li n e + A p p li c a ti o n s revolutionizing the science of nerve repair® E d u c a te S u rg e o n s , D e v e lo p A d
Slide 25: Strong commitment to developing clinical evidence
Outcomes from RANGER Registry 48,49 25 P IL L A R 3 Strong commitment to developing clinical evidence RANGER® Registry Study: Enrollment Ongoing • Multi-center clinical study in PNR with >2,700 enrolled to date • Overall meaningful recovery rates of 82-84%; comparable to autograft MATCH® Registry St
Slide 26: RECON study design
RECONSM: A Multicenter, Prospective, Randomized, Subject & Evaluator Blinded Comparative Study of Nerve Cuffs & Avance Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities 26 Safety & efficacy non- inferiority comparison of Avance vs conduit Evaluated upper extremity digi
Slide 27: RECON Study Topline Results
revolutionizing the science of nerve repair® RECON Study Topline Results1,2 27 Statistical superiority demonstrated at increasing gap lengths ✓ Avance demonstrated statistical superiority for return of sensory function (measured by static two-point discrimination) as compared to conduits in gaps gre
Slide 28: Independent Publication of Nerve Meta-Analysis
Independent Publication of Nerve Meta-Analysis Provides the Strongest Clinical and Economic Evidence To-Date of the Performance of Avance® Nerve Graft Across All Gap Lengths and Nerve Types 28 • Analyzed 35 peer-reviewed studies with 711 allograft, 670 autograft, and 178 conduit repairs, over four d
Slide 29: Procedure Costs of Peripheral Nerve Graft Reconstruction
Procedure Costs of Peripheral Nerve Graft Reconstruction Raizman et al. PRS Global Open1 29revolutionizing the science of nerve repair® • Retrospective study of U.S. all-payer data on facility procedure costs from 2018 to 2020. Included over 1,300 nerve repairs. Conclusions: • No significant differe
Slide 30: Focus on building awareness among clinicians and patients
30 Focus on building awareness among clinicians and patients • Increasing omnichannel engagement with clinicians and patients • Continuing clinical conference participation both virtually and in-person as appropriate • Ongoing patient ambassador program • Garnering positive media attention • Growing
Slide 31: Continued education and advocacy efforts
Knowledge is power: continued education and advocacy efforts with patients, clinicians and key legislators elevates the problems associated with numbness.
Slide 32: Emphasis on education
32 P IL L A R 2 Emphasis on education • In-person and virtual national education programs • Customized multimodal learning programs to specific surgeon groups for advanced learning • Ongoing interactive webinar series covering the principles of nerve repair • Emphasis on training hand and micro- sur
Slide 33: Focused sales execution, increasing market penetration
33 P IL L A R 4 Focused sales execution, increasing market penetration P IL L A R 3 E x e c u te S a le s P la n Sales execution focused on driving results • Continue driving penetration in Active and Core Accounts • Approximately 5,100 potential U.S. accounts perform nerve repair • 974 Active Accou
Slide 34: Expand the opportunity in nerve repair
34 P IL L A R 5 Expand the opportunity in nerve repair P IL L A R 4 P IL L A R 3 E x p a n d P ro d u c t P ip e li n e & A p p li c a ti o n s Breast Neurotization Loss of breast sensation affects Quality of Life Urology Prostatectomy OMF Iatrogenic nerve injuries, mandible tumor resections affects
Slide 35: Committed to our patients and communities
Committed to our patients, the communities we serve, and our pursuit of advancing the science of nerve repair in ethical and sustainable ways Diversity, Equity, and Inclusion - Being the Company where exceptional people want to work Cybersecurity – Data Privacy, Training, and Policies Compliance – Q
Slide 36: Executive team
Executive team 36 Erick DeVinney VP, Peripheral Nerve Science and Clinical Innovation Angiotech, PRA Intl Mike Donovan VP, Operations Zimmer Ivica Ducic, M.D., Ph.D. Medical Director Washington Nerve Institute Angelo Scopelianos, Ph.D. Chief Research & Development Officer J&J Peter J. Mariani Execut
Slide 37: The Axogen platform for nerve repair
37 The Axogen platform for nerve repair revolutionizing the science of nerve repair® • Exclusively focused on peripheral nerve repair with a differentiated platform • 10+ years of demonstrated clinical outcome consistency • Over 200 peer-reviewed clinical publications • Over 75,000 Avance® Nerve Gra
Slide 38: Appendix
Appendix • Key Clinical Data • Historical Core and Active Accounts • CMS outpatient and ASC reimbursement rates • Total Addressable Market • Cash, debt, and capital structure • Axogen product portfolio and indications for use 38revolutionizing the science of nerve repair®
Slide 39: Avance Nerve Graft repairs significantly better than conduit repairs
Avance Nerve Graft repairs found to be significantly better than conduit repairs 39 • Peer-reviewed publication from the MATCH cohort of the RANGER Registry • Includes outcomes from 110 subjects with 162 nerve injuries; 113 were repaired with Avance Nerve Graft and 49 were repaired with manufactured
Slide 40: Avance recovery rates comparable to nerve autograft
Study finds Avance Nerve Graft (allograft) clinical outcomes recovery rates comparable to nerve autograft 40 “Safa et al., A Propensity Matched Cohort Study on Outcomes from Processed Nerve Allograft and Nerve Autograft in Upper Extremity Nerve Repairs”49 Presented at American Society for Surgery of
Slide 41: Breast neurotization outcomes with Avance Nerve Graft
First publication on breast neurotization outcomes with Avance Nerve Graft demonstrated greater return of protective sensation 41 • Early outcomes from a single center study, as part of the Sensation-NOW registry • 36 breast reconstructions that included: 22 breast reconstructions with Resensation®
Slide 42: REPOSE pilot study analysis
Axogen sponsored REPOSESM pilot study analysis demonstrates clinically significant improvement for subjects with chronic neuropathic pain when using Axoguard Nerve Cap® following neurectomy60 42 15-subject, single arm pilot phase evaluating reduction in pain from baseline following surgical excision
Slide 43: Historical Active and Core Accounts
Historical Active and Core Accounts Active Accounts typically contribute ≈85% of total revenue Top 10% of Active Accounts typically contribute ≈35% of total revenue Active Accounts 6 orders in the last 12 months Core Accounts typically contribute ≈60% of total revenue Core Accounts ≥$100,000 revenue
Slide 44: CMS outpatient and ASC reimbursement rates
CPT Code Descriptor C-APC Hospital Outpatient (HOPD) Ambulatory Surgery Center (ASC) 2019 2023 2024 Proposed 5Y % Change 2019 2023 2024 Proposed 5Y % Change 64912 Nerve allograft repair2 5432 $4,566 $6,179 $6,504 42.44% $1,920 $4,057 $4,638 141.56% 64910 Conduit or vein allograft repair2 5432 $4,566
Slide 45: 2024 CMS Proposed Physician Fee Schedule
2024 Center for Medicare and Medicaid Services (CMS): Proposed Physician Fee Schedule (PFS) revolutionizing the science of nerve repair™ 45August 7, 2023 CPT Codes3 Descriptor Physician Fee Schedule (PFS) 2019 2023 2024 Proposed 5Y % Change 64912 Nerve allograft repair $804 $908 $883 9.8% 64910 Cond
Slide 46: Estimated Trauma total addressable market
46 Estimated Trauma total addressable market revolutionizing the science of nerve repair®
Slide 47: Trauma total addressable market (continued)
Trauma total addressable market (continued) 47revolutionizing the science of nerve repair®
Slide 48: Estimated Total Addressable Market
Projected Incidence(a) Weighted Average Procedure Value Estimated Total Addressable Market Trauma Transection injuries >5mm (b) Transection injuries <5mm Protection (c) 700,000 100% 203,000 29% 198,000 29% 293,000 42% $2,715 $5,515 $1,200 $1,825 $1,900M 100% $1,120M 59% $238M 12% $535M 28% Carpal an
Slide 49: Growth opportunity in the trauma market
$238 $1,901 $453 $675 $535 <5mm nerve injuries Digital & other sensory nerves >5mm Mix/Motor >5mm Protection Total Trauma Market US Nerve Repair Trauma Categories ($M) We continue to see a significant growth opportunity in the trauma market as we leverage new clinical & HE data and product launches,
Slide 50: Balance Sheet Highlights
50 Balance Sheet Highlights June 30, 2023 Cash, Cash Equivalents, and Investments $40.8 million Total Long-term Debt $50.0 million* Capital Structure (shares) June 30, 2023 Common Stock 42,979,541 Common Stock Options, RSUs, PSUs 8,587,824 Common Stock and Common Stock Equivalents 51,567,365 Balance
Slide 51: Axogen comprehensive portfolio of products
Axogen comprehensive portfolio of products Avance® Nerve Graft • Regulatory Classification: Avance Nerve Graft is processed and distributed in accordance with U.S. Food and Drug Administration (FDA) requirements for Human Cellular and Tissue-based Products (HCT/P) under 21 CFR Part 1271 regulations,
Slide 52: Axogen comprehensive portfolio of products (Cont'd)
Axogen comprehensive portfolio of products (Cont’d) revolutionizing the science of nerve repair™ 52August 7, 2023 • Axoguard HA+ Nerve Protector ® • Regulatory Classifications: Class II Medical Devices - 510(k) cleared • Indication for Use: Axoguard HA+ Nerve Protector is indicated for the managemen
Slide 53: nasdaq: axgn 53revolutionizing the science of nerve repair®
nasdaq: axgn 53revolutionizing the science of nerve repair®
Slide 54: Footnotes
54 Footnotes Trauma Market Data: 1. National Hospital Ambulatory Medical Care Survey: 2015 Emergency Department Summary Tables – Table 18. https://www.cdc.gov/nchs/data/nhamcs/web_tables/2015_ed_web_tables.pdf 2. Noble, et al.. Analysis of Upper and Lower Extremity Peripheral Nerve Injuries in a Pop
Slide 55: Footnotes
55 Footnotes 38. Galeano M, et al. A free vein graft cap influences neuroma formation after nerve transection. Microsurgery. 2009;29(7):568-572. 39. Stokvis A. Surgical management of painful neuromas. Rotterdam, The Netherlands: Optima Grafische Communicatie; 2010. 40. Lin E, et al. Local administra
Slide 56: The Axogen platform for nerve repair
56 The Axogen platform for nerve repair revolutionizing the science of nerve repair® • Exclusively focused on peripheral nerve repair with a differentiated platform • 10+ years of demonstrated clinical outcome consistency • Over 200 peer-reviewed clinical publications • Over 75,000 Avance® Nerve Gra